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Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

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ClinicalTrials.gov Identifier: NCT01950572
Recruitment Status : Recruiting
First Posted : September 25, 2013
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

September 21, 2013
September 25, 2013
March 2, 2018
September 21, 2013
December 31, 2030   (Final data collection date for primary outcome measure)
sample aquisition [ Time Frame: Ongoing ]
allow sample acquisition for use in the study of mesothelioma
Allow sample acquisition for use in the study of mesothelioma [ Time Frame: ongoin ]
Complete list of historical versions of study NCT01950572 on ClinicalTrials.gov Archive Site
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Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers

Background:

  • Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis.
  • Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States.
  • The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis.
  • Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease.

Objectives:

-To allow sample acquisition for use in the study of mesothelioma.

Eligibility:

  • All patients age greater than or equal to 2 years with malignant mesothelioma
  • Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18

Design:

  • Up to 1000 subjects will be enrolled.
  • Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma.
  • Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking.
  • Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.

Background:

  • Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis.
  • Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States.
  • The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis.
  • Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease.
  • In addition to mesothelioma, mesothelin is highly expressed in several cancers, including pancreatic, biliary adenocarcinomas, gastric and ovarian cancers; mesothelin is also expressed in a significantly larger proportion of thymic carcinoma than thymoma.
  • Mesothelin expression level has been correlated with improved overall survival in thymic cancer and with reduced overall survival in patients with lung cancer.

Objective:

-To allow sample acquisition for use in the study of mesothelioma and other mesothelin expressing cancers.

Eligibility:

  • All patients age greater than or equal to 2 years with malignant mesothelioma
  • All patients age greater than or equal to 2 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers
  • Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18

Design:

  • Up to 1000 subjects will be enrolled.
  • Patients will be followed to determine the course of disease and to record any treatment received for the eligible mesothelin expressing cancer.
  • Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking.
  • Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Persons with a diagnosis of any of the thoracic or GI cancers under study.
  • Mesothelioma
  • Thymoma
  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms
  • Stomach Neoplasms
Not Provided
1/Eligible cancer diagnosis
Subjects with mesothelioma, thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Same as current
December 31, 2030
December 31, 2030   (Final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:
  • All patients greater than or equal to 2 years of age with malignant mesothelioma.
  • All patients greater than or equal to18 years of age with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers.
  • Confirmed pathological diagnosis is required
  • Ability and willingness of subject to provide informed consent to participation.

EXCLUSION CRITERIA:

  • Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
  • Pregnant or breast feeding women will be eligible for this protocol, but will not undergo tumor biopsy.
  • Active concomitant medical or psychological illnesses that may increase the risk to the subject or in adult patients, inability to obtain informed consent, at the discretion of the principal investigator.
Sexes Eligible for Study: All
2 Years to 100 Years   (Child, Adult, Older Adult)
No
Contact: Maria Agra (301) 594-1106 mariagracia.agra@nih.gov
Contact: Raffit Hassan, M.D. (240) 760-6232 rh276q@nih.gov
United States
 
 
NCT01950572
130202
13-C-0202
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National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
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Principal Investigator: Raffit Hassan, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
February 23, 2018